The 2011 food safety law gave the FDA the power to force a recall of food if there is a reasonable probability it is adulterated or misbranded and could cause serious illness or death. The law says FDA must give the responsible party an opportunity to issue a recall before ordering a mandatory recall.

Prior to the FSMA, the FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

The FDA first released its mandatory recall guidelines in 2015. The final document, released Nov. 5, includes some changes based on comments the agency received.

The FDA outlined the steps it would take if a company refuses to recall a product, for example, that has been linked to an E. coli or salmonella outbreak.

“If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than two days after the issuance of the order,” according to the FDA.

After those steps, the FDA can order a recall under section 423(d) of the Food, Drugs and Cosmetics Act. Only the FDA commissioner, currently Scott Gottlieb, has the authority to order a recall under section 423(d).

Rarely-used authority

FDA has issued a mandatory recall of food only once, in April, for products containing powdered kratom manufactured, processed, packed or held by Triangle Pharmanaturals LLC after several products were found to contain salmonella.

In two other instances, FDA began the process of using mandatory recall authority, but the companies ultimately chose to recall the products.

The agency said it “remains committed” to working with firms on food recalls.

In comments to the FDA on the rule, the Produce Marketing Association said the agency must be sure that a food under mandatory recall is “indeed the food vehicle” causing or is reasonably likely to cause severe adverse health consequences or death.

“While swift identification and recall of a food that is likely to cause severe adverse health consequences or death is an absolute necessity, so is assuring to the greatest extent possible that the food vehicle has been correctly identified,” PMA said in its 2015 comment.

The FDA’s final guidance holds no surprises, said Jennifer McEntire, vice president of food safety and technology for the United Fresh Produce Association.

“It is helpful to see the sort of parameters under which they will use that (authority),” she said.

“I would expect (mandatory recall) will be very rarely used because I think that companies do recognize that they need to act,” she said. P